New CMS Guidance on Medicare Drug Pricing Initiatives
On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) released new draft guidance outlining the processes and requirements for implementing the maximum fair price (MFP) for certain prescription drugs under Medicare in 2028. This initiative, part of the Medicare Drug Price Negotiation Program established under the Inflation Reduction Act of 2022, aims to negotiate reduced drug prices for high-cost single-source drugs and biological products.
The draft guidance elaborates on the effectuation policies for MFP applicable in 2028, focusing on selected drugs covered under Medicare Parts B and D. These updates will supersede specific sections of previous MFP guidelines established for 2026 and 2027, ensuring a consistent approach to regulatory compliance requirements.
This new draft outlines procedures impacting various stakeholders, such as drug manufacturers, Medicare Part D plan sponsors, Medicare Advantage organizations, pharmacies, and healthcare providers under Part B. The procedures are designed to streamline how the MFP is managed and accessed by eligible Medicare beneficiaries, improving the claims process and reducing potential delays.
Interested parties have until September 18, 2026, to submit comments on the draft guidance. Feedback can be sent via email to the CMS, contributing to the development of the final guidance expected to be released later this year, which will refine the regulatory framework for effective implementation.
The guidance also introduces the use of a Medicare Transaction Facilitator (MTF) for handling information exchange between manufacturers and healthcare providers. Utilizing the MTF Data Module and Payment Module ensures compliance with negotiated drug prices by verifying claims and facilitating accurate payments.
The guidance provides options for determining a standardized refund amount for Part B drugs, based on existing pricing metrics like the Wholesale Acquisition Cost or the Average Sales Price. This approach aims to simplify the calculation of potential refunds that manufacturers must provide when the actual acquisition cost exceeds the MFP, supporting transparent underwriting practices.
Lastly, CMS has clarified the conditions under which the MFP does not apply due to existing 340B agreements, highlighting the importance of careful nonduplication of discounts. To ensure effective implementation, CMS plans to update information collection processes for MTF onboarding, adjusting operations based on stakeholder feedback from previous experiences. Stakeholders can access further resources about the Medicare Drug Price Negotiation Program policies and guidance on the CMS website.